Gutset

COMPOSITION

Gutset Suspension: Each 5 ml suspension contains Domperidone BP 5 mg.

INDICATIONS

1. Dyspeptic symptom complex, often associated with delayed gastric emptying, Gastroesophageal reflux and esophagitis: Epigastric sense of fullness, flatulence, Nausea and vomiting, Diabetic gastroparesis, Non-ulcer dyspepsia. 2. Acute nausea and vomiting of functional, organic, infectious, induced by radiotherapy or drug therapy. 3. Parkinson’s disease: In dopamine-agonist induced nausea and vomiting.

DOSAGE AND ADMINISTRATION

The usual recommended oral dose of Gutset (Domperidone) is as follow: Adults: 10-20 ml Gutset (Domperidone) suspension, every 4-8 hours daily. Children: 2-4 ml Gutset (Domperidone) suspension/10 kg body weight, every 4-8 hours daily. In dyspeptic symptom: The recommended oral dose for Adults: 10-20 ml Gutset (Domperidone) suspension, every 4-8 hours daily. Children: 0.2-0.4 mg/Kg (2-4 ml Gutset (Domperidone) suspension/10 Kg) body weight, every 4-8 hours daily. In acute and sub-acute conditions (mainly in acute nausea and vomiting): The recommended oral dose for Adults: 20 ml Gutset (Domperidone) suspension, every 4-8 hours daily Children: 0.2-0.4 mg/Kg (2-4 ml Gutset (Domperidone) suspension/10 Kg) body weight, every 4-8 hours daily.

CONTRAINDICATIONS

Gutset (Domperidone) is contraindicated to patients having known hypersensitivity to this drug and in case of neonates. Gutset (Domperidone) should not be used whenever gastro-intestinal stimulation might be dangerous i.e., gastro-intestinal hemorrhage, mechanical obstruction or perforation.

PRECAUTIONS

Gutset (Domperidone) should be used with absolute caution in case of children because there may be increased risk of extra-pyramidal reactions in young children because of an incompletely developed blood-brain barrier. Since Gutset (Domperidone) is highly metabolized in liver, it should be used with caution in patient with hepatic impairment

SIDE EFFECTS

Gutset (Domperidone) may produce hyperprolactinemia (1.3%). This may result in breast enlargement, soreness and reduced libido. Dry mouth (1%), thirst, headache (1.2%), nervousness, drowsiness (0.4%), diarrhea (0.2%), skin rash and itching (0.1%) may occur during treatment with Gutset (Domperidone).

DRUG INTERACTIONS

Gutset (Domperidone) may reduce the risk of hypoprolactemic effect of bromocriptine. The action of Gutset (Domperidone) on GI function may be antagonized by antimuscarinics and opoid analgesics. Care should be exercised when Gutset (Domperidone) is administered in combination with MAO (monoamine oxidase) inhibitors.

USE IN PREGNANCY AND LACTATION

Pregnant woman: The safety of Gutset (Domperidone) has not been proven and it is therefore not recommended during pregnancy. Lactating mother: Gutset (Domperidone) may precipitate galactorrhea and improve postnatal lactation. It is secreted in breast milk but in very small quantities insufficient to be considered harmful.

STORAGE PRECAUTIONS

Store in a cool and dry place. Protect from light and moisture. Keep out of the reach of children.

COMMERCIAL PACK

Gutset Suspension : Bottle containing 60 ml suspension.

Manufactured by:

Ad-Din Pharmaceuticals Ltd.